GlaxoSmithKline plc (GSK) today announced the start of a Phase III study to evaluate Benlysta® (belimumab) in patients with ANCA (Anti-neutrophil Cytoplasmic Antibodies) positive vasculitis – a condition that involves inflammation of the blood vessels.
The multi-centre, multi-national, randomised, double-blind study will evaluate the efficacy and safety of belimumab in combination with azathioprine for the maintenance of remission in patients with a particular type of vascultitic disease called ANCA associated Vasculitis (Granulomatosis with Polyangiitis (Wegener’s) or microscopic polyangiitis).
Belimumab is not approved for use anywhere around the world for vasculitic disease.
Vasculitis is a condition where the body’s immune system attacks blood vessels leading to inflammation of the blood vessels. This results in disruption of blood flow which can in turn damage the body’s organs. The signs and symptoms of vasculitis vary depending upon which organs have been damaged and the extent of the damage.
Vasculitic diseases are classified according to the predominant size of vessel involved.ANCA – associated vasculitis is the most common primary systemic small-vessel vasculitis to occur in adults. Granulomatosis with Polyangiitis (Wegener’s) and Microscopic Polyangiitis are two classifications of ANCA-vasculitis with a combined estimated prevalence of 102 – 284 per milllion in the US and 178-284 per million in Europe.
About Benlysta (belimumab)
Belimumab is the first in a drug class known as BLyS-specific inhibitors. It was first approved by the U.S. Food and Drug Administration in 2011 for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE or lupus) who are receiving standard therapy. It was also approved by the European Commission in 2011 as add-on therapy in adult patients with active, autoantibody-positive SLE with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy. Its use has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, HIV, a history of, or current, hepatitis B or C, hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl), a history of major organ transplant or hematopoietic stem /cell /marrow transplant or renal transplant; and it has not been studied in combination with other biologics or intravenous cyclophosphamide. Its use is not recommended in these situations.
Important Safety Information
Benlysta (belimumab) is contraindicated in patients who have had anaphylaxis with belimumab. Additional risks include: Mortality: There were more deaths reported with belimumab than with placebo during the controlled period of clinical trials; Serious Infections: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including belimumab. Use with caution in patients with chronic infections. Consider interrupting belimumab therapy if patients develop a new infection during belimumab treatment; Malignancy: As with other immunomodulating agents, the mechanism of action of belimumab could increase the risk of malignancies; Hypersensitivity Reactions, Including Anaphylaxis: Serious and fatal reactions have been reported. Belimumab should be administered by healthcare providers prepared to manage anaphylaxis. Monitor patients during and for an appropriate period of time after administration of belimumab; Depression: Depression and suicidality have been reported in belimumab studies. Patients should be instructed to contact their healthcare provider if they experience new or worsening depression,suicidal thoughts or other mood changes; Immunization: Live vaccines should not be given concurrently with belimumab; Adverse Reactions: Common adverse reactions (≥5%) in clinical trials were: nausea, diarrhea,pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.